Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency.

Documentation Guideline Adherence Humans Marketing Research Personnel United States United States Food and Drug Administration
Bioresearch monitoring Clinical investigator Good clinical practice inspection Inspection finding Sponsor

Journal

Therapeutic innovation & regulatory science
ISSN: 2168-4804
Titre abrégé: Ther Innov Regul Sci
Pays: Switzerland
ID NLM: 101597411

Informations de publication

Date de publication:
09 2022
Historique:
received: 04 02 2022
accepted: 28 04 2022
pubmed: 25 5 2022
medline: 10 8 2022
entrez: 24 5 2022
Statut: ppublish

Résumé

The United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) have collaborated in good clinical practice (GCP) inspections since September 2009. The two agencies operate under different regulatory frameworks for GCP oversight. No systematic assessments of GCP inspection findings have been reported. We identified common inspections of clinical investigators, sponsors, and contract research organizations conducted by both agencies in support of marketing applications that had the same trial data submitted between 2009 and 2015. We grouped inspection findings into deficiency areas. We reviewed and compared these findings and calculated concordance rate for each deficiency area. Twenty-six clinical investigator sites and 23 sponsors/contract research organizations were inspected by both agencies in support of 31 marketing applications during this period. For FDA, the most common GCP findings were deficiencies related to Protocol Compliance for clinical investigator inspections and Trial Management issues for sponsor/contract research organization inspections. For EMA, deficiencies related to Documentation (including Trial Master File) were the most common findings for both clinical investigator and sponsor/contract research organization inspections. There was high concordance, of approximately 90%, for deficiencies related to Protocol Compliance for clinical investigator inspections and Trial Management for sponsor/contract research organization inspections between the two agencies. There was a concordance rate of about 70% for Documentation deficiencies for both clinical investigator and sponsor/contract research organization GCP inspections. GCP inspection findings from 49 common clinical investigator and sponsor/contract research organization inspections were comparable, providing support for continued FDA-EMA GCP collaboration.

Sections du résumé

BACKGROUND
The United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) have collaborated in good clinical practice (GCP) inspections since September 2009. The two agencies operate under different regulatory frameworks for GCP oversight. No systematic assessments of GCP inspection findings have been reported.
METHODS
We identified common inspections of clinical investigators, sponsors, and contract research organizations conducted by both agencies in support of marketing applications that had the same trial data submitted between 2009 and 2015. We grouped inspection findings into deficiency areas. We reviewed and compared these findings and calculated concordance rate for each deficiency area.
RESULTS
Twenty-six clinical investigator sites and 23 sponsors/contract research organizations were inspected by both agencies in support of 31 marketing applications during this period. For FDA, the most common GCP findings were deficiencies related to Protocol Compliance for clinical investigator inspections and Trial Management issues for sponsor/contract research organization inspections. For EMA, deficiencies related to Documentation (including Trial Master File) were the most common findings for both clinical investigator and sponsor/contract research organization inspections. There was high concordance, of approximately 90%, for deficiencies related to Protocol Compliance for clinical investigator inspections and Trial Management for sponsor/contract research organization inspections between the two agencies. There was a concordance rate of about 70% for Documentation deficiencies for both clinical investigator and sponsor/contract research organization GCP inspections.
CONCLUSION
GCP inspection findings from 49 common clinical investigator and sponsor/contract research organization inspections were comparable, providing support for continued FDA-EMA GCP collaboration.

Identifiants

DOI: 10.1007/s43441-022-00417-w PMID: 35610469 PMC: PMC9356921
pubmed: 35610469
doi: 10.1007/s43441-022-00417-w
pii: 10.1007/s43441-022-00417-w
pmc: PMC9356921
doi:

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

753-764

Commentaires et corrections

Type : ErratumIn
Type : ErratumIn

Informations de copyright

© 2022. This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply.

Références

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pubmed: 29489839
PLoS One. 2014 Dec 17;9(12):e115063
pubmed: 25517976
Curr Clin Pharmacol. 2013 May;8(2):115-23
pubmed: 22963351
Perspect Clin Res. 2016 Apr-Jun;7(2):62-7
pubmed: 27141471
Med Etika Bioet. 2002 Spring-Summer;9(1-2):12-9
pubmed: 16276663
Clin Pharmacol Ther. 2020 Nov;108(5):949-963
pubmed: 31958142
N Engl J Med. 2009 Feb 19;360(8):816-23
pubmed: 19228627

Auteurs

Jenn W Sellers (JW)

Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, United States Food and Drug Administration, 10903 New Hampshire Ave, White Oak Building 51, Room 5324, Silver Spring, MD, 20993, USA. jenn.sellers@fda.hhs.gov.

Camelia M Mihaescu (CM)

Inspections Office, Quality and Safety of Medicines Department, European Medicines Agency (EMA), Domenico Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands.

Kassa Ayalew (K)

Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, United States Food and Drug Administration, 10903 New Hampshire Ave, White Oak Building 51, Room 5324, Silver Spring, MD, 20993, USA.

Phillip D Kronstein (PD)

Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, United States Food and Drug Administration, 10903 New Hampshire Ave, White Oak Building 51, Room 5324, Silver Spring, MD, 20993, USA.

Bei Yu (B)

Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, United States Food and Drug Administration, 10903 New Hampshire Ave, White Oak Building 51, Room 5324, Silver Spring, MD, 20993, USA.

Yang-Min Ning (YM)

Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, United States Food and Drug Administration, 10903 New Hampshire Ave, White Oak Building 51, Room 5324, Silver Spring, MD, 20993, USA.

Miguel Rodriguez (M)

Inspections Office, Quality and Safety of Medicines Department, European Medicines Agency (EMA), Domenico Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands.

LaKisha Williams (L)

Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, United States Food and Drug Administration, 10903 New Hampshire Ave, White Oak Building 51, Room 5324, Silver Spring, MD, 20993, USA.

Ni A Khin (NA)

Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, United States Food and Drug Administration, 10903 New Hampshire Ave, White Oak Building 51, Room 5324, Silver Spring, MD, 20993, USA.

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Classifications MeSH

questionsmedicales.fr › Sciences de l'information › Sources d'information › Services d'information › Documentation › Descriptive Analysis of Good Clinical Practice...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Adhésion aux directives › Descriptive Analysis of Good Clinical Practice...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Descriptive Analysis of Good Clinical Practice...
questionsmedicales.fr › Technologie, industrie et agriculture › Commerce › Marketing › Descriptive Analysis of Good Clinical Practice...
questionsmedicales.fr › Personnes › Groupes professionnels › Personnel de recherche › Descriptive Analysis of Good Clinical Practice...
questionsmedicales.fr › Régions géographiques › Amériques › Amérique du Nord › États-Unis › Descriptive Analysis of Good Clinical Practice...
questionsmedicales.fr › Organisations et économie des soins de santé › Organismes › Gouvernement › Agences gouvernementale américaines › Department of Health and Human Services (USA) › Public Health Service (USA) › Food and Drug Administration (USA) › Descriptive Analysis of Good Clinical Practice...